MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT ACETABULAR SHELL Ø50 TWO-HOLES; HIP CEMENTLESS SHELL

Catalog Number 01.32.150DH

Device Problem Device Appears to Trigger Rejection (1524)

Patient Problem Unspecified Infection (1930)

Event Date 12/12/2023

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 21-dec-2023: lot 2247232: (b)(4) items manufactured and released on 29-mar-2023.Expiration date: 2028-03-13.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.Additional devices involved batch review performed on 21-dec-2023: liner: mpact 01.32.3241hct flat pe hc liner ø32/d (k103721) lot 2247616: (b)(4) items manufactured and released on 10-feb-2023.Expiration date: 2028-01-25.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.Ball heads: mectacer 01.29.205 biolox delta ceramic ball head 12/14 ø 32 size m 0 (k112115) lot 2318432: (b)(4) items manufactured and released on 26-jul-2023.Expiration date: 2028-07-04.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.

Event Description

At about 1 month and a half after the primary, the patient came in due to signs of infection and the pathogen is unknown.The surgeon performed a washout and explanted the cup, liner and head.A bipolar head and biolox head were implanted to act as a temporary spacer as part of the 2-stage infection protocol.The surgery was completed successfully.Permanent implants will be put in at a later date.

• Brand Name: MPACT ACETABULAR SHELL Ø50 TWO-HOLES
• Type of Device: HIP CEMENTLESS SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 18473115
• MDR Text Key: 332375479
• Report Number: 3005180920-2023-01078
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 07630030810763
• UDI-Public: 07630030810763
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132879
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 01.32.150DH
• Device Lot Number: 2247232
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/14/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/29/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female